The Comprehensive Department of the State Food and Drug Administration solicits comments on the revised draft of the "Catalogue of Class I Medical Devices"

On August 18, the Comprehensive Department of the State Food and Drug Administration issued a public solicitation of comments on the revised "Catalogue of Class I Medical Devices" (draft for comments)

The original text is as follows:

The Comprehensive Department of the State Food and Drug Administration publicly solicits opinions on the revised draft of the "Catalogue of Medical Devices Product Catalog" (Draft for Solicitation of Comments)

In order to deepen the reform of the medical device review and approval system, further guide the filing of the first category of medical devices, and boost the high-quality development of the medical device industry, the State Food and Drug Administration organized the drafting of the revised draft of the "Catalogue of First Category Medical Devices" (soliciting comments) Draft) and revised instructions (Annex 1-2) are now open for comments

Please fill in the feedback form (Attachment 3) and send it to mdct@nmpa.

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Comprehensive Department of State Food and Drug Administration

August 17, 2021

Annex 1 The revised draft of the first category medical device catalog (draft for soliciting comments)

01 Equipment

02 Passive surgical instruments

03 Nerve and Cardiovascular Surgical Instruments

04 Orthopedic surgical instruments

05 Radiotherapy equipment

06 Medical imaging equipment

07 Medical examination and monitoring equipment

10 Blood transfusion, dialysis and extracorporeal circulation equipment

11 Medical equipment disinfection and sterilization equipment

14 Infusion, nursing and protective equipment

15 Patient Carrying Device

16 ophthalmic equipment

17 Stomatological equipment

18 Obstetrics and Gynecology, assisted reproduction and contraceptive devices

19 Medical rehabilitation equipment

20 Traditional Chinese Medicine Equipment

22 clinical testing equipment

"06-08-01 Ultrasonic Couplant", "09-02-03 Physical Cooling Device", "09-03-08 Light Therapy Equipment Accessories", "14-10-02 Wound Plaster", and "14" in the first category of medical device catalog -10-08 "Liquid, paste dressing" products must not contain traditional Chinese medicine, chemical drugs, biological products, disinfection and antibacterial ingredients, natural plants and their extracts, etc.